Test area for prevention of specimen tampering in substance abuse testing

ABSTRACT

The invention provides a method and a test area to prevent tampering in the collection of specimens for substance abuse testing from a subject utilizing a specimen collection container. More particularly, the present invention prevents the substitution of the subject by another person and prevents the subject from introducing a previously obtained and concealed false specimen while minimizing intrusion on the subject&#39;s privacy.

This application is a continuation in part of application Ser. No.07/401,107 filed Aug. 31, 1989, now U.S. Pat. No. 5,039,616.

BACKGROUND OF THE INVENTION

This invention relates to a method and a test area to prevent tamperingin the collection of specimens for substance abuse testing and, moreparticularly, to prevent tampering in the collection of specimens forsubstance abuse testing from a subject utilizing a specimen collectioncontainer.

In recent years, a considerable amount of attention has been focused onthe social and economic, as well as other, consequences of substanceabuse, that is the use of illegal drugs, the illegal or deleterious useof legally controlled drugs, or the deleterious use of freely availabledrugs including alcohol. The efforts to control and eradicate substanceabuse and the consequences thereof encompass many diverse strategies;however, a feature common to many of these approaches places a strongemphasis on the testing of specimens from human subjects to determinewhether substance abuse has occurred. Not only is such testing conductedas part of many programs concerned with matters in the nature ofdrug/alcohol rehabilitation and probation and parole of criminaloffenders (e.g., no substance abuse as a condition of parole: drunkdriving) but it is also increasingly required as a condition of gainingor retaining employment, particularly where safety or integrity isimportant (e.g., airline pilots, railroad engineers, truck drivers, andpublic officials). In each case, the subject who abuses such substanceshas a considerable social and financial incentive to tamper withspecimens which would indicate substance abuse upon testing, that istest positive. For instance, depending on the subject's circumstances, apositive test could mean denial or loss of employment and thereforeincome, dismissal from military service, change in parole or probationstatus, criminal prosecution, designation as a chronic abuser, and/ordesignation as a security risk.

In order to foil detection a subject may tamper with a substance abusetest in at least two ways. One way is to substitute another person, onewho is not a substance abuser, for the actual subject. Another way isfor the subject to introduce a false specimen instead of his own duringthe specimen collection process. A false specimen is defined as: (1) aspecimen given by the subject at a prior time when drug-free; (2) aspecimen obtained by the subject from another person; or (3) a substancewith properties similar to that of a specimen which is free ofdetectable amounts of the substance that is to be tested for, and whichis concealed beforehand and introduced by the subject instead of a validspecimen.

Concerns for protecting the fundamental privacy and dignity of subjectsdictate against direct observation of the subject during specimencollection as a means of preventing introduction of a false specimen.While protecting the important privacy interests of subjects, presentlyknown methods overly rely on the individual honesty of subjects andattendant personnel thus presenting a variety of opportunities fortampering. Identification procedures are not always rigorous and asubstitute may appear instead of the true subject. If the identificationprocedure is adequate, a dishonest or lax attendant may not adhere toit. If the subject is properly identified, subsequent inadequate ordishonest supervision of the testing area may allow someone else tosubstitute for the subject. Finally, as mentioned hereinabove, aproperly identified subject, particularly in the privacy of a toilet,may introduce a false specimen obtained and concealed beforehand.

Thus, recent studies show that up to 40 percent of urine specimens givenin employee substance abuse testing programs are false. Presently knownmethods of specimen collection rely on measuring specimen temperatureand comparing it to normal body temperature to determine whether or nota specimen is false. These methods, however, permit subjects tosuccessfully introduce false specimens with ease. For instance, old,drug-free samples of the subject's urine or substances having properties(e.g., pH, color, density) similar to urine are held under the armpit bythe subject in order to raise the false specimen's temperature toapproximately body temperature, thus foiling detection.

SUMMARY OF THE INVENTION

It is therefore a principal object of the present invention to provide amethod which prevents the substitution of the subject by another personand prevents the subject from introducing a previously obtained andconcealed false specimen, and to accomplish this while minimizingintrusion on the subject's privacy.

It is a further object of the present invention to provide a test areawhich enables the method of this invention to be used.

The test area of the present invention comprises: a registry, which ispreferably computerized; a toilet compartment having a closable entranceand at least one toilet compartment sidewall, said sidewall having atleast one aperture assembly containing an aperture, said toiletcompartment preferably having a first toilet compartment sidewall and asecond toilet compartment sidewall, preferably the first sidewall havinga first aperture assembly containing a first aperture and the secondsidewall having a second aperture assembly containing a second aperture;a connecting area between said registry area and said toiletcompartment; a specimen collection container dispenser; a specimencollection container deposit area; and preferably at least onemonitoring camera positioned in said test area such that the monitoringcamera views substantially all of the registry, the closable entrance ofthe toilet compartment, the connecting area therebetween, the interiorof the toilet compartment when the entrance is open, the apertureassembly, and the specimen collection container deposit area to enableessentially continuous monitoring of the subject, except when thesubject is within the closed toilet compartment, from the start ofsubject identification until the subject discharges a specimen into thespecimen collection container and deposits, in accordance with aprescribed deposit procedure, the filled specimen collection containerin the deposit area. Monitoring by attendant personnel in lieu of, or inaddition to, the monitoring camera is also contemplated.

The method of the present invention, for preventing tampering in thecollection of a specimen from a subject utilizing a container for use bythe subject to either receive the specimen or to dispense a taggingsubstance for ingestion by the subject, comprises the steps of: (1)identifying a subject using an individual-specific subjectidentification; (2) delivering said container to said subject andpreventing substitution of the container or the identified subject byessentially continuously monitoring the identified subject and thecontainer until the identified subject effects proper use of thecontainer and relinquishes the container; and (3) preventingintroduction of a false specimen. According to the present invention,introduction of a false specimen is prevented by restricting the actionsof the identified subject while the subject is within the closed toiletcompartment, by measurement of specimen temperature, and/or byadministration of a tagging substance to the subject.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary and the following detailed description of theinvention will be better understood when read in conjunction with theaccompanying drawings, in which:

FIG. 1 is a diagrammatic plan view of a test area constructed inaccordance with one embodiment of the invention;

FIG. 2 is a diagrammatic sectional view along line 2--2 of FIG. 1;

FIG. 3 is a diagrammatic sectional view along line 3--3 of FIG. 1;

FIG. 4 is a fragmentary diagrammatic plan View illustrating the specimencollection container deposit area and the first aperture assembly;

FIG. 5 is a face view along line 5--5 of FIG. 4 illustrating the firstaperture assembly;

FIG. 6 is a fragmentary sectional view along line 6--6 of FIG. 4illustrating the first aperture assembly;

FIG. 7 is a front view of a toilet compartment of a test areaconstructed in accordance with another embodiment of the invention;

FIG. 8 is an enlarged side view of an embodiment of a hand-hold of thetest area illustrated in FIG. 7;

FIG. 9 is a perspective view of an alternative embodiment of a hand-holdof the test area illustrated in FIG. 7;

FIG. 10 is a top plan view of the toilet compartment of the test areaillustrated in FIG. 7;

FIG. 11 is a sectional view taken along line 11--11 of FIG. 10;

FIG. 12 is a side elevational view of one embodiment of a portablespecimen container;

FIG. 13 is a side elevational view of another embodiment of a specimencontainer with temperature measuring devices attached thereto; and

FIG. 14 is a cross sectional view taken along line 14--14 of FIG. 13.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings, FIG. generally illustrates one embodiment ofthe test area of the present invention, designated generally as 10. Thetest area 10 of the preferred embodiment of the present inventionincludes a closable entrance 15 leading to a computerized registry 26, atoilet compartment 42 having a toilet 49, a closable entrance 45 and afirst toilet compartment sidewall 46 and a second toilet compartmentsidewall 48, the first sidewall 46 containing a first aperture assembly50, the second sidewall 48 containing a second aperture assembly 52; aconnecting area 43 between the registry and the toilet compartment; aspecimen collection container deposit area 56; and a first monitoringcamera 22 and preferably a second monitoring camera 24 positioned in thetest area that the cameras together substantially view the registry area26, the closable entrance of the toilet compartment, the connecting area43 therebetween, the first aperture assembly 50, the second apertureassembly 52, and the specimen collection container deposit area 56 toenable continuous monitoring of the subject, except when the subject iswithin the closed toilet compartment, from the start of subjectidentification until the subject voids a specimen into a specimencollection container and deposits, in accordance with a prescribeddeposit procedure, the filled specimen collection container in thedeposit area 56.

The word "specimen" as used herein includes body fluids such as urine,blood, semen, and saliva. In the description that follows, the inventionwill be described with reference to collection of a urine specimen.Those skilled in the art will understand that the present invention maybe readily utilized for the collection of specimens of other body fluidsincluding saliva, semen, and blood.

More generally, the architecture of a particular test area is influencedby a number of factors including cost, importance of the testing, andthe incentives for deception by the particular subject population. Thetechnology required to construct the various embodiments of the testarea is well known, readily available, and is usable with little or nomodification. In the preferred embodiment, as illustrated in FIGS. 1, 2,and 3, the rectangular, enclosed test area 10 comprises a first sidewall14 and a second sidewall 16, each connected to a rear wall 12 having ahinged first door 11 attached thereto and a front wall 13. The subjectenters the test area through a first door 11 and approaches thecomputerized registry 26 while being kept within the view of a firstmonitoring camera 22 by a first barrier rail 18 and a second barrierrail 20, each rail having two ends, each rail being fixedly attached atone end to rear wall 12 and at the other end to first sidewall 14 andsecond sidewall 16, respectively.

The registry is preferably computerized, thereby permitting automatedsubject identification. In the preferred embodiment illustrated in FIG.2, registry 26, which is operable by the subject, includes a keyboard 28and a registry card-reader 30 with which the subject may enter apreviously assigned identification number on the registry computer.Instructions are transmitted automatically to the subject via messagescreen 34, however, such instructions, or any other necessaryinformation, may be communicated to the subject via screen 34 or anintercom by attendant personnel. The registry preferably includes anautomated scanner 32 able to scan a substantially individual-specificphysical characteristic of the subject, and compare the determinedcharacteristic with a pre-existing record of the substantiallyindividual-specific physical characteristic for the purpose of subjectidentification.

Preferably, this substantially individual-specific characteristic is thepalm-crease pattern of the subject's hand. The palm-crease pattern is aphysical characteristic that is practical for automated identification.Optical scanning of the palm pattern has already been applied to medicalscreening. It can be used to confirm individual identities because thevariability of palm patterns allows the detection of individualdifferences with ample sensitivity. The scan is immediate, simple toperform, independent of an attendant, and is readily computer coded. Thesubject is merely required to place a hand on the scanning plate 32 fora few seconds. The scan does not require ink or stain, and does not havethe unpleasant connotation of fingerprinting. The scan is codeddigitally and compared automatically with the on-file pattern. A matchcan be used to dispense containers automatically while a mismatch may besignalled to a responsible authority.

In special situations, thumb-printing may be used as one alternative topalm-scanning. Its accuracy exceeds the requirements for testing, and itis more acceptable to many subjects than full fingerprinting.Thumb-printing can be performed by an untrained subject. A staining padand a print blank are dispensed by the registry. The thumb is pressed onthe pad and then on the blank. The print is scanned and processed in thesame way as the palm-crease pattern.

Although not presently as practical as palm-scanning or thumb-printing,other individual-specific physical characteristics may possibly be usedin subject identification. Such characteristics include: visual patternsof the ear, iris, and entire face; dental patterns; voice profiles; and,conventional fingerprints among others. Depending on whether or not thescan and on-file physical characteristics match, the registry isequipped to perform a set of preselected actions. If there is a match,the preselected action includes assignment of an identifying indicia,such as an identification number to the specimens to be collected andcausing container dispenser 38 to automatically dispense and/or label,with subject-specific information including date, time, file number, andspecimen number, a specimen collection container at area 40. Thepreselected action may also include causing dispenser 38 to dispense atarea 40 a container holding a predetermined amount of an ingestibletagging substance of known composition. If there is a mismatch, thepreselected action may include recordation of the mismatch in thesubject's registry file. Such recordation can include notification of aresponsible authority concerning the mismatch.

The test area monitoring camera can be controlled and/or viewed from amonitoring station which can be in a location remote from the test area.Such a camera may be continuously or periodically monitored by attendantpersonnel. The camera can also record whatever it views, thus allowingrelief or total replacement of attendant personnel who view the cameraimage by periodic review of the recorded images at some time after theactual specimen collection occurs. The camera record includes a display,preferably continuous, of the date and time, the latter preferably tothe second. Preferably, the date and time are continuously recorded byat least one monitoring camera from the date-time display 36, fixedlymounted on the registry. Monitoring by attendant personnel in lieu of,or in addition to, the monitoring camera is also contemplated.

The toilet compartment of the test area provides the subject withprivacy while voiding a specimen for collection. These test specimensare usually urine specimens and preferably the design of the toiletcompartment reflects this fact. To prevent the introduction of a falsespecimen by an identified subject, having a first hand and a secondhand, in the privacy of the closed toilet compartment, means for handmonitoring may be used to restrict the subject's actions. The toiletcompartment has at least one wall which contains at least one apertureassembly, viewable by the monitoring camera. The subject must insert hisfirst hand through an aperture such that the hand is viewable by amonitoring camera. Only then may the subject insert his second handthrough the same aperture or a second aperture to retrieve the emptyspecimen collection container dispensed from dispenser 38 and placed ona specimen collection container holder which is exterior with respect tothe toilet compartment and adjacent an aperture. The specimen collectioncontainer holder can be a bottle holder, rack, small platform, orsimilar device.

In the preferred embodiment, a first toilet compartment sidewall 46 anda second toilet compartment sidewall 48 are connected at one end tofront wall 13 and define at the other end a closable entrance 45therebetween, said entrance being closable by a door 44. Sidewalls 46and 48 contain, respectively, a first aperture assembly 50 and a secondaperture assembly 52. The sidewalls 46 and 48 are approximately in linewith the viewing axes of monitoring cameras 22 and/or 24. The plane ofthe aperture of each aperture assembly being approximately parallel tothe viewing axes of cameras 22 and 24, the apertures themselves are notdirectly visible by either camera.

In the preferred embodiment, illustrated diagrammatically in FIGS. 4, 5,and 6, each aperture assembly comprises a collar 62 to which is mounteda flap 64, of cloth, plastic or other suitable material, by flap hinge66. The flap provides subjects with a greater sense of privacy. Toprovide even a greater sense of privacy, the aperture may be fitted witha sleeved, glove-like extension or a loose fabric sack to enclose theextended hand. It is also contemplated to provide an aperture with orwithout a glove or flap to allow the subject a choice of which side ofthe compartment to receive and deposit the specimen container. If atoilet compartment sidewall, and the aperture assembly contained thereinare aligned with a monitoring camera viewing axis such that the apertureis at least partially viewable directly by a monitoring camera, thewidth of collar 62 may be adjusted such that any direct camera view ofthe aperture is obstructed by the collar.

In the preferred embodiment, the subject, upon proper identification, isdispensed a specimen collection container by container dispenser 38. Thesubject then places the container in specimen collection containerholder 54 and only then enters the toilet compartment. Once the subjectcloses the door 44, the subject must insert one hand through secondaperture assembly 52 such that the hand is visible to camera 22. Onlythen may the subject insert the other hand through the first apertureassembly 50 and retrieve the specimen collection container in view of atleast one monitoring camera.

Alternatively, upon closing the toilet compartment door, the subject maybe permitted to insert one hand through aperture assembly 50 such thatthe hand is visible to camera 22 and then insert the other hand throughthe same aperture assembly to retrieve the specimen collection containerin view of at least one monitoring camera. Introduction of a falsespecimen is prevented by restricting the subject's actions in that thesubject is required to keep the one free hand in view of a monitoringcamera at all times that the specimen collection container is inside thetoilet compartment and thus not in view of a monitoring camera. Eachaperture should be large enough to accommodate both of the subject'shands and the specimen collection container simultaneously so as toallow the subject to change the hand holding the container while atleast one hand is continuously monitored.

Alternatively, for greater privacy, the subject can be restricted to theuse of one hand for specimen collection without being required to keepthe free hand in view of the monitoring camera, by use of a means forhand monitoring located within the toilet compartment. The subject maybe required to keep the free hand emplaced continuously upon a full-handcontact as seen in FIG. 9 or five-finger contact signalling device asillustrated in FIGS. 7 and 8. For example one hand-hold 70 illustratedin FIG. 8 is preferably mounted on each of the sidewalls 46 and 48 asshown in FIG. 7, one of which may be activated to accommodate aright-handed or left-handed subject, but a single hand hold may bedeemed sufficient. The hand position on the hand-hold is confirmed byremote illuminating or mechanical signals 77 and 78, which are activatedupon depression of the thumb switch button 72 and each of the fingerswitch buttons 74 protected by a finger switch guard 76. As illustratedin FIG. 9, the hand-hold 100 alternatively may have a full-hand lever102 and switch 106, and a thumb switch 104. Additionally, a remoteilluminating or mechanical signal 79 is activated when the cover 110 tothe fixed specimen container 71 is retracted. The compartment is alsopreferably provided with written instructions 83 and an intercom 75 forcommunication with the subject.

If two hand holds are used in the compartment, it is preferable torequire the subject to depress the thumb switch on each of thehand-holds simultaneously to generate a valid signal. It is alsodesirable to include a switch guard 76 which impedes the subject fromdepressing the switches with a foreign object such as an elastic band orstrap. The electrical connections of the hand contact device 70 may beprogrammed to accommodate a subject that is lacking or has handicappedfingers and thumb. If the subject fails to maintain contact with thesignalling device for the appropriate time, the device signals aresponsible authority and preferably records the event in the subject'sregistry record. The approximate time includes the time at which thesubject returns the specimen collection container to the view of amonitoring camera.

In another embodiment, two opposed hand-holds, or apertures, are usedsimultaneously, and a fixed specimen container within the compartment isprovided as illustrated in FIGS. 10 and 11. The specimen container 71 isheld by the container holder 73 which are both fixedly attached insidethe compartment. Hand-holds 70 are provided on both sides of thespecimen container for the subject's hands. After the subject places hishands on the hand-holds 70 and depresses the proper switches, theclosure or lid 110 having rollers 116 connected thereto by hinges 112which covers the specimen container is retracted by suitable mechanicalmeans 118 such as pulleys, rods, hydraulic cylinders, or the like. If atany time the subject removes his hands from the hand-holds, theretracting means releases the lid 110 which is then pushed back over thespecimen container by a suitable mechanical means such as a compressionspring 114.

The freedom of movement of the subject's hand used for specimencollection, which-is not continuously monitored, may be furtherrestricted by use of a suitably shaped and equipped specimen collectioncontainer holder 80 as illustrated in FIG. 12. Two features of such acontainer holder 80 or container 81 require the subject's hand to becompletely occupied or engaged in holding the container in order for thesubject to be able to void into it. First, the container holder 80 orcontainer 81 is shaped such that it cannot stand unsupported and must beheld upright to be filled. For example, such a container holder 80 mayhave a bottom shape 80a which approximates a hemisphere, as seen in FIG.12, a parabola, a cone, or an elliptically-truncated cylinder.

Second, the container holder 80 or container 81 is constructed such thatit must be held open to be filled. In its closed position, a lid 82covers the standard specimen container 81 which is supported by and fitsinto the container holder 80. The lid is continuously forced closed, forexample, by a spring (not shown) in the handle 84 of the containerholder 80. To void into the container, the subject must open the lid 82by simultaneously depressing the thumb button 86 and clenching the handlever 88, having a guard 92, to oppose the action of the spring 90. Thiscombined action triggers either a mechanical or electronic mechanism inthe handle 84 which causes the lid to pivot counterclockwise as seen inbroken lines in FIG. 12 about its pivot pin 94. If the subject releaseseither the thumb button 86 or the hand lever 88, the lid is forcedclosed by a spring or other means. The subject, therefore, cannot usethe unmonitored hand to introduce a false specimen into the specimencollection container while in the privacy of the toilet compartment. Thefilled specimen collection container is deposited by the subject in thespecimen collection container deposit area 56 by passing the containerthrough the aperture 50 while keeping the other hand in its monitored orrestricted position.

The specimen container may also be equipped with a protective grill orscreen 87 to prevent injury to the subject's genitalia. The grill 87 isdesigned to allow the lid 82 to open freely and also allows urine tofreely flow through into the container. The grill however prevents thesubject's genitalia from becoming impinged between the container holder80 or the container 81 and the lid 82. The grill 87 is preferably shapedto prevent urine from dripping down the grill and over the side of thecontainer holder 80 and has a suitably-shaped splash guard 85 which goesabout two-thirds way around the screen.

Preferably, the deposit area 56 is equipped with a deposit receptacle 58from which filled containers are not retrievable by the subject. Thedeposit area is preferably equipped to measure and record thetemperature of the specimen upon deposit. The temperature of freshlyvoided urine specimens is limited to the narrow range of the body's coretemperature, which is usually above ambient temperature. If the specimenis significantly outside such predetermined temperature range, it is notfresh and cannot be a true specimen for the test. To duplicate bodytemperature in a substituted specimen, the subject would need to performseveral actions. The subject would need to adjust the false specimenrather precisely to body temperature, store and keep the specimen (e.g.,urine) in a concealed container while maintaining the narrow temperaturerange, remove and open the container of the false specimen and introducethe false specimen into the specimen collection container.

Specimen temperature measurement using readily available technologypermits interdiction of such false specimens. In one embodiment, thespecimen temperature is measured by internal means for temperaturemeasurement inaccessible to the subject. The term "internal" comprehendsmeans which are specific to a particular specimen collection container.Such means include a clinical-type thermometer which is automaticallydispensed to the subject in the deposit area and inserted by him intothe container under surveillance by the monitoring camera. Aclinical-type thermometer, which records within its range only themaximum temperature to which it is exposed, is preferred because urinetemperature decreases rapidly after voiding, and the object is to insurethat the specimen is freshly voided. This type of thermometer requiresthat the container be stored where the ambient temperature is below thetemperature range of the human body. In either case, the temperaturemeasuring device is not dispensed, available or used until the specimenis brought into view of the monitoring camera.

In another preferred embodiment as seen in FIGS. 13 and 14, a containersimilar in size and shape to a standard specimen container is equippedwith a clinical-type thermometer 130 or other maximum recordingthermometer and/or a current-registering thermometer 129 fixed byadhesive or mechanical fittings 124 to the inside surface of thecontainer 121. Thermometer bulb guards 126 are also provided inside thecontainer. Once a specimen is voided, the lid 128 of the container 121or cover 82 of the container encloses the specimen and the thermometers.

In another embodiment, the clinical-type thermometer of the typeillustrated in FIGS. 13 and 14 is fixedly attached to the closure or topof the specimen collection container. In yet another embodiment thecontainer is formed with a well-like depression for receiving a metalprobe of narrow diameter or a thermocouple, preferably in the bottomwall of the container, to allow an extrinsic device to measure thecurrent temperature.

In another embodiment, specimen temperature is measured by an externalmeans for temperature measurement 60. The term "external" refers totemperature measurement devices which are not specific for eachindividual specimen collection container but rather to devices installedin the deposit area which measure specimen temperature when applied tothe specimen collection container or the content thereof undersurveillance by the monitoring camera. Such means include thermocouplesand similar devices.

If visual monitoring is not used, the temperature should not be measuredand recorded until the filled container is closed and cannot be reopenedby the subject. A thermocouple or other temperature-measuring device canthen record the temperature of each specimen at the time it isdeposited. Alternatively, an individual thermometer or thermometers inthe top or body of the container may be used. Such thermometer must notbe accessible to the subject or exposed to the specimen until closure bya seal or catch that reveals any subsequent reopening. Devices thataccomplish this include a thermometer with a connection completed byclosing the container or one with a shield that is stripped by theaction of closure.

The method of the present invention, for preventing tampering in thecollection of a specimen from a subject utilizing a container for use bysaid subject to either receive the specimen or to dispense a taggingsubstance for ingestion by said subject, comprises the steps of:

(a) identifying a subject using an individual-specific subjectidentification;

(b) delivering said container to said subject and preventingsubstitution of the container or said identified subject by essentiallycontinuously monitoring said identified subject and the container untilsaid identified subject effects proper use of the container andrelinquishes said container; and

(c) preventing introduction of a false specimen.

According to the present invention, introduction of a false specimen isprevented by restricting the actions of the identified subject while thesubject is within the closed toilet compartment, by measurement ofspecimen temperature, and/or by administration of a tagging substance tothe subject. Verification of the subject's identity is essential toprevent specimen tampering in a substance abuse testing program.Preferably, the method of the present invention correctly identifies thesubject automatically by use of a computerized registry, hereinbeforedescribed. Advantageously, the present method does not depend on thehonesty of the subject or attendant personnel.

In the preferred embodiment, the subject uses a registry keyboard or acard-pass and registry card-reader to enter a previously issuedsubject-specific file number. In practice, the card can include adigitalized description of the subject's identifying substantiallyindividual-specific physical characteristic to reduce registry filespace requirements and file costs, as well as to reduce error and tospeed identification. The registry determines a substantiallyindividual-specific physical characteristic of the subject, compares thedetermined characteristic with a pre-existing record of that physicalcharacteristic, and then performs a preselected action involved ininitiating the specimen collection procedure. Preferably, thesubstantially individual-specific physical characteristic utilized foridentification purpose is the subject's palm-create pattern, detected byan optical scanner as hereinbefore described. The registry preferablyrecords a variety of data including date and time of the subject'sappearance, the subject's file number, the digital description of thesubject's substantially individual-specific physical characteristic, theresults of the comparison between the determined physical characteristicand the pre-existing record of that physical characteristic, and thetime and container identification number, if any, whenever any containeris dispensed or deposited.

The preselected action includes dispensing of a specimen collectioncontainer only when said determined substantially individual-specificphysical characteristic matches the pre-existing record of that physicalcharacteristic. Also, the preselected action can include labelling thespecimen collection container with indicia when the determined physicalcharacteristic matches the pre-existing record of the physicalcharacteristic. The container label preferably includes the subject filenumber as well as an individual container identification number.Additionally, the preselected action can include notification of aresponsible authority when the determined physical characteristic doesnot match the pre-existing record of the physical characteristic.Preferably, the occurrence of such a mismatch is recorded in thesubject's registry file.

To prevent another person from substituting for the identified subject,preferably a monitoring camera, hereinbefore discussed, monitors thesubject continuously, except when the subject is within the closedtoilet compartment, while the subject is in the test area from the timethe identification procedure starts until the filled specimen collectioncontainer is deposited properly, or a tagging substance is ingested bythe subject thereby eliminating the need for further subject observationin the test area. Once the identified subject has ingested a taggingsubstance, the subject need no longer be monitored. Analysis of thesubject's specimen for the tagging substance will reveal whethersubstitution of the specimen, the specimen collection container or ofthe identified subject has occurred.

The method of the present invention contemplates preventing introductionof a false specimen, hereinbefore defined, by the subject while in theprivacy of the toilet compartment, by use of any combination of thefollowing means. According to the present invention, introduction of afalse specimen is prevented by restricting the actions of the identifiedsubject while the subject is within the closed toilet compartment, bymeasurement of specimen temperature, and/or by administration of atagging substance to the subject. Advantageously, the present methodprevents false specimen introduction while protecting the subject'sprivacy interest and dignity during specimen collection.

In the ingested-tagging substance embodiment, a tagging substance,ingested by the subject during a predetermined period before voiding thespecimen, identifies the specimen as that of the actual subject, voidedduring the test period. The present method, utilizing this procedure,comprises the steps of:

(a) assigning a predetermined amount of said ingestible taggingsubstance of known composition to said subject for said specimen to becollected;

(b) recording said assignment in a registry file also containingidentifying information on said subject;

(c) administering said tagging substance to said subject upon subjectidentification, whereby said tagging substance becomes present in a bodyfluid from which said specimen is collected;

(d) collecting said specimen from said subject;

(e) determining the presence or amount of said tagging substance in saidspecimen;

(f) comparing the results of said tagging substance determination withsaid recorded assignment and identifying information.

Preferably, three containers are dispensed to the subject under camerasurveillance either sequentially, or together if identifiably differentto the monitoring camera, to insure use in the correct order. The firstcontainer is preferably sealed and contains the tagging substance,preferably in liquid form. The subject ingests the tagging substance inview of the monitoring camera, inverts the empty container for thecamera to view and deposits the container in a receptacle that preventsunauthorized retrieval. The second container, preferably sealed, isfilled with water and is similarly ingested, inverted and deposited inview of the camera. These steps insure that only the subject has accessto the tagging substance assigned and that the subject ingests it.Finally, the specimen collection container is dispensed and monitoringof the subject can be terminated.

This method advantageously does not require monitoring once the taggingsubstance is ingested, allowing the subject a period of freedom in whichto void the specimen. Tagging substances may include a broad variety offood dyes, commercial flavors, vitamins, trace elements and otherharmless substances or their isomers. Tagging substances may beidentified by known techniques such as mass spectrometry at the time thespecimen is tested for abused substances. Even if a subject coulddiscover the identities of all the tagging substances used in a testingprogram, the chance of matching a specific subject's tagging group wouldbe prohibitively small. The probability for such a match is limited bythe number of different tagging substances, and the number ofcombinations thereof, used for the entire subject population and thenumber of tagging substances administered to each subject. A specimenmay be collected immediately before the tagging substance is dispensed:comparing this specimen with the one collected after the taggingsubstance is ingested eliminates the possibility of confusion ordeception if a substance similar to the tagging substance is ingestedbefore the test.

Introduction of a false specimen while in the privacy of a toiletcompartment can be made difficult by restricting one hand of a subjecthaving a first hand and a second hand, thereby limiting the subject touse of one hand only when filling the specimen collection container. Thepresent method, utilizing this hand-restriction procedure, comprises thefollowing steps:

(a) providing a toilet compartment having a first toilet compartmentsidewall, the sidewall having at least one aperture assembly containingan aperture, which assembly is visible to a monitoring camera;

(b) causing the subject to place an empty specimen collection containeradjacent to the aperture such that the container is visible to themonitoring camera;

(c) causing the subject to enter the toilet compartment;

(d) causing the subject to expose the first hand to means for handmonitoring until the subject completes steps (e)-(g);

(e) causing the subject to bring the specimen collection containerinside the toilet compartment through the aperture by use of the secondhand;

(f) causing the subject to discharge the specimen into the specimencollection container;

(g) causing the subject to place the filled specimen collectioncontainer outside of the toilet compartment through an aperture suchthat the container is visible to the monitoring camera;

(h) causing the subject to remove the first hand from exposure to themeans for hand monitoring and to exit the toilet compartment.

In one embodiment wherein said toilet compartment is provided with onlythe first aperture assembly defining a first aperture, the means forhand monitoring include causing the subject to pass the first handthrough the aperture such that the hand is viewable by a monitoringcamera. In the preferred embodiment, the means for hand monitoringinclude a second aperture assembly defining a second aperture in thetoilet compartment wall, or preferably in the second toilet compartmentwall, through which the first hand is passed such that it is viewable bythe monitoring camera as hereinbefore described.

Alternatively, for greater privacy, the subject can be restricted to theuse of one hand without being required to keep one hand in view of themonitoring camera by use of a means for hand monitoring located withinthe toilet compartment. The subject is required to keep his first handemplaced upon a full-hand contact or five-finger contact signallingdevice until a predetermined instance. If the subject fails to do so,the device signals a responsible authority and preferably records theevent in the subject's registry record. The predetermined instanceincludes the point at which the subject returns the specimen collectioncontainer to the view of the monitoring camera.

The subject's second hand, which is not continuously monitored, may befurther restricted by use of a suitably shaped and equipped specimencollection container as seen in FIG. 12. The subject, therefore, cannotuse the unmonitored hand to introduce a false specimen into the specimencollection container and thus does not have either hand free whilefilling the container within the privacy of the toilet compartment.

The terms and expressions which have been employed are used as terms ofdescription and not of limitation, and there is no intention in the useof such terms and expressions of excluding any equivalents of thefeatures shown and described, or portions thereof, but it is recognizedthat various modifications are possible within the scope of theinvention claimed.

I claim:
 1. A test area to prevent tampering while collecting a specimenfrom a subject by restricting and monitoring the location of thesubject's hands, said area comprising:a registry for subjectidentification; a monitoring device; a toilet compartment having aclosable entrance, toilet compartment sidewalls, and a hand detectingmeans for use in detecting when at least one hand of the subject islocated in a predetermined position; and a specimen collectingcontainer, said container having means for preventing voiding into saidcontainer until at least one hand of the subject is located in apredetermined position.
 2. A test area according to claim 1 wherein thehand detecting means comprises a hand-hold, said hand-hold having meansfor detecting when a hand of the subject is in a predetermined positionon said hand-hold and signalling means for providing a signal to saidmonitoring device when a hand of the subject is in said predeterminedposition on said hand-hold.
 3. A test area according to claim 2 whereinthe hand detecting means further comprises a second hand-hold, said twohand-holds fixedly mounted to opposed sidewalls, said specimencollecting container fixedly attached inside said toilet compartment,said specimen container having a closure for preventing voiding intosaid container unless the subject's hands are continuously located onsaid hand-holds.
 4. A test area according to claim 3 further comprisingmeans for opening said closure when the subjects hands are located onsaid two hand-holds, said opening means being remote from saidcompartment, said monitoring device having means for activating saidopening means.
 5. A test area according to claim 3 further comprisingmeans for automatically opening said closure when the subject's handsare located on said two hand-holds, said opening means being remote fromsaid compartment.
 6. A test area according to claim 2 wherein saidsignalling means comprises an electronically activated display visibleto said monitoring device.
 7. A test area according to claim 2 whereinsaid hand-hold comprises an independent thumb switch and a fingerswitch, said switches activating said signalling means when saidswitches are simultaneously and continuously activated.
 8. A test areaaccording to claim 7 further comprising a switch guard for preventingactivation of said finger switch by means other than the subject'sfingers.
 9. A test area according to claim 7 wherein said finger switchcomprises a single hand lever.
 10. A test area according to claim 1wherein said hand detecting means comprises an aperture in one saidsidewall, whereby a hand of the subject is visible to said monitoringdevice when it is placed through said aperture.
 11. A test areaaccording to claim 10 wherein said aperture comprises cloaking means forobscuring visibility through said aperture and allowing free passage ofthe subject's hands through said aperture.
 12. A test area according toclaim 10 wherein said specimen container comprises a portable hand-heldcontainer having a closure which must be held open continuously by handin order for said container to be filled, said container having a baseshaped such that said container requires hand support to stand upright.13. A test area according to claim 12 wherein said specimen containercomprises a container hand-hold with independent thumb and finger meanswhich must be activated simultaneously and continuously for opening saidclosure when the subject activates said thumb and finger means.
 14. Atest area according to claim 13 wherein said portable hand-heldcontainer comprises a standard specimen container and container holderfor receiving said standard specimen container.
 15. A test areaaccording to claim 1 wherein said specimen container comprises meansfixedly attached to said container adapted for receiving means formeasuring the temperature of the specimen voided into said container.16. A test area according to claim 1 wherein said specimen containercomprises means for measuring the temperature of the specimen voidedinto said container.
 17. A test area according to claim 16 wherein saidtemperature measuring means comprises a standard current temperaturethermometer and a maximum temperature thermometer.
 18. A test areaaccording to claim 1 wherein said monitoring device is a monitoringcamera located in said test area to allow said camera to viewsubstantially all of said registry, and said closable entrance of saidtoilet compartment, to enable continuous monitoring of said subject,except when the subject is within the closed toilet compartment, fromthe start of said subject identification until said subject voids aspecimen into the specimen collection container and deposits, inaccordance with a prescribed deposit procedure, said collectioncontainer containing said specimen into a deposit area.